emergency use authorization approved

Ortho Clinical Diagnostics Gets Emergency Use Authorization for COVID-19 Test

August 10, 2021

Raritan, N.J.-based Ortho Clinical Diagnostics’ new VITROS Anti-SARS-CoV-2 Total N antibody test has received an Emergency Use Authorization from the FDA.

The test, which is designed to detect the tested individual's immune response or total antibodies to the COVID-19 virus, is intended to help clinicians understand if the patient had a recent or prior COVID-19 infection.

Laboratories can process up to 150 antibody tests or up to 130 antigen tests in one hour on Ortho’s VITROS System, the company said.

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